Different batches of atorvastatin, represented by two immediate release formulation designs, were studied using a novel dynamic dissolution apparatus, simulating stomach and small intestine. A universal dissolution method was employed which simulated the physiology of human gastrointestinal tract, including the precise chyme transit behavior and biorelevant conditions. The multicompartmental dissolution data allowed direct observation and qualitative discrimination of the differences resulting from highly pH dependent dissolution behavior of the tested batches. Further evaluation of results was performed using IVIVC/IVIVR development. While satisfactory correlation could not be achieved using a conventional deconvolution based-model, promising results were obtained through the use of a nonconventional approach exploiting the complex compartmental dissolution data.

Department of Applied Pharmacy Faculty of Pharmacy University of Veterinary and Pharmaceutical Sciences Brno Palackého 1 3 612 42 Brno Czech Republic

Department of Chemical Drugs Faculty of Pharmacy University of Veterinary and Pharmaceutical Sciences Brno Palackého 1 3 612 42 Brno Czech Republic ; Department of Internal Medicine Hematology and Oncology Faculty of Medicine Masaryk University Kamenice 5 625 00 Brno Czech Republic

Department of Pharmaceutical Technology and Biopharmaceutics Faculty of Pharmacy Jagiellonian University Medical College Medyczna 9 Street 30 688 Kraków Poland

Department of Pharmacoepidemiology and Pharmacoeconomics and Department of Social Pharmacy Faculty of Pharmacy Jagiellonian University Medical College Medyczna 9 Street 30 688 Kraków Poland ; Simcyp Limited Blades Enterprise Centre John Street Sheffield S2 4SU UK

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